BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3052855 · Received April 10, 2013

    Report

    Report Number
    MW5029705
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CONCEPTUS, INC
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE REACTIONS TO ESSURE PERMANENT BIRTH CONTROL SYSTEM. SHE SAID IMMEDIATELY AFTER IMPLANTATION PROCEDURE, SHE FELT SORE, WHICH SHE THOUGHT WAS NORMAL. HOWEVER, SHE STATED 5 DAYS AFTER IMPLANTATION, SHE BEGAN TO FEEL NAUSEOUS WHEN EATING, HAD EXTREME LOWER ABDOMINAL PAIN, HEAVY BLEEDING, DISCOMFORT AND A BURNING/TINGLING FEELING IN THE LEFT SIDE OF HER ABDOMEN SPREADING TO THE RIGHT SIDE. PT SAID SHE HAS ABDOMINAL SWELLING, IS IN CONSTANT PAIN, AND THE PRESCRIBED PAIN MEDICATIONS ARE NOT HELPING. SHE SAID SHE IS SCHEDULED TO HAVE A HYSTERECTOMY (B)(6) 2013 FOR DEVICE REMOVAL. SHE SAID SHE HAD TESTS DONE THAT RULED OUT ANY GI PROBLEMS AS THE CAUSE FOR HER PAIN. SHE ALSO MENTIONED A CT SCAN FOUND A CYST ON HER OVARY, BUT THAT TOO WAS RULED OUT AS A CAUSE FOR HER PAIN AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152340 ESSURE PERMANENT BIRTH CONTROL SYSTEM HHS CONCEPTUS, INC A64637

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other